CERSI Collaborators: Mark Schlesinger, PhD (Yale) (PI), Joseph Ross, MD, MHS (Yale)

FDA Collaborators: Vasum Peiris, MD, MPH (FDA PI)

Project Start: October 25, 2018

Regulatory Science Challenge

Stakeholders have raised concerns about a lack in the availability of devices designed and tested for children. Congress passed the Safe Medical Devices Act of 1990 as well as the Pediatric Medical Device Safety and Innovation Act in 2007 to help encourage the development of medical devices for underserved populations, including children. Despite these actions, there has been little improvement in the number of devices developed for children over the last 30 years. Numerous factors complicate the development of pediatric devices, including challenges in clinical trial participation, variations in anatomy and pathophysiology, and reaching small, unique, and geographically isolated populations. Creating a marketplace that supports development of technologies which serve the complexities of children may help medical technology innovation for all Americans.

Project Description and Goals

The aim of this project is to understand how the current regulatory environment influences business decision-making as it relates to developing devices for pediatric populations. Through a survey, researchers aim to identify company motivators for innovation, design, and pediatric device testing. Barriers preventing companies from designing, testing, and submitting pediatric devices to the FDA will also be assessed.

Goal 1: Understand how the current regulatory environment influences business decision-making, particularly as it relates to developing devices for children and special populations

Goal 2: Identify strategies that incentivize innovation and foster a supportive marketplace for technologies that improve care for children and special populations